Medical Devices

Recommended Prerequisites

  Related knowledge (Pharmaceutical Technology, Pharmacology, Human Physiopathology and Pharmacotherapy); generic skills (analysis and synthesis, information management, critical thinking, independent learning, applying theoretical knowledge in practical problem solving and ability to investigate); specific skills (known instruments, devices, implants, in vitro reagent, and similar materials used to diagnose, prevent, treat diseases or other conditions.).

As the field of linguistic competence, Portuguese and English in order to meet the objectives set by the course.

Teaching Methods

In order to achieve the objectives set for the course, the teaching methodology used is:

Lectures

Expository method supported by electronic means (basically slides and videos)

Group work (4 students)

Monograph on a medical device and public scrutiny.

Induction for student participation in scientific like.

Evaluation:

Monograph/ Examination (100% of the final grade).

Learning Outcomes

In education, promotion and maintenance of health rely not only with the knowledge and involvement of different professionals, but also with a wide range of products that support and assist in the prevention, diagnosis and control of disease, injury or disability. In this context, medical devices have grown exponentially in number, both in variety, so sometimes it is not easy to classify them.

The efficacy and safety of medical devices are of paramount importance to good health care, so it became imperative in recent years to create the conditions to ensure the quality of these products.

Aims of this course to acquaint future pharmacists the current legal context in which medical devices are inserted, as well as provide knowledge to act at any stage of the life cycle of these products.

Work Placement(s)

No

Syllabus

Part I

Medical devices and applicable law

1 . Introduction

2 . Insertion of medical devices in the world of health products

3 . Cycle of medical devices

4 . Non-active medical devices

5 . Bodies of guardianship

6 . Procedures for the selection of non-active medical devices

6.1 General legal requirements

6.2 Legal requirements for class

7 . Technical procedures of non-active medical devices

7.1 Storage and distribution / dispensing

7.2 Monitoring system

7.3 Collection and disposal

8 . Conclusion

Part II

Assessment and pharmacist counseling

9 . Oral Hygiene

10 . Evaluation of  respiratory function

11 . Contact Lenses

12 . Individuals ostomates Care

13. Dressings

14. Bandages

15. Catheters.

Head Lecturer(s)

João Carlos Canotilho Lage

Assessment Methods

Final assessment
Exam: 100.0%

Continuous assessment
Synthesis work: 100.0%

Bibliography

Decreto-Lei nº 145/2009, de 17 de Junho.
- Guidelines for Vigilance System: “Guidelines on a Medical Devices Vigilance System”, MEDDEV 2.12/1 Rev. 5 April
2007.
- Guideline for classification: “Guideline for the classification of medical devices”, MEDDEV 2.4/1, Rev 8, July 2001.
- Guideline for medical device with a measure function: “Guidelines related to the application of: the Council
Directive 90/385/EEC on Active Implantable Medical Devices, the Council Directive 93/42/EEC on Medical Devices –
Medical devices with a measure function). MEDDEV 2.1/5 June 1998.
- Guideline for definitions of “medical devices”, “accessory” and “manufacturer”: “Guidelines related to the
application of: the Council Directive 90/385/EEC on Active Implantable Medical Devices, the Council Directive
93/42/EEC on Medical Devices”, MEDDEV 2.1/1 April 1994.
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